STAT

SEPTEMBER 26, 2024

Pfizer’s decision Wednesday to pull its sickle cell pill off the market because of safety concerns shocked advocates and doctors, leaving many searching for answers and scrambling for ways to notify their patients about a drug that has long divided the community.  The move underscored the severity of the risks recently seen in studies of the drug, Oxbryta , in which researchers have reported a number of deaths among patients who were receiving it.

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PharmaVoice

SEPTEMBER 26, 2024

KarXT’s approval demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.

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STAT

SEPTEMBER 26, 2024

For decades, doctors caring for people with schizophrenia have relied on mood-regulating drugs that target the brain chemical dopamine. On Thursday, the Food and Drug Administration approved for the first time a new type of medicine that may change the way the psychiatric disorder is treated.  The drug, called Cobenfy, will be sold by Bristol Myers Squibb.

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PharmaVoice

SEPTEMBER 26, 2024

Roivant CEO Matt Gline leads the company on a unique path by placing bets on misfit drugs and technologies — and it’s working.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Communication

STAT

SEPTEMBER 26, 2024

SILVER SPRING, Md. — Food additives rarely face FDA scrutiny once they’re on the market, even those with mounting evidence of safety concerns. At a meeting held by the Food and Drug Administration on Wednesday, regulators said they plan to change that.  The public meeting on the FDA’s campus drew dozens of food safety advocates, industry representatives, concerned citizens, and state and federal lawmakers.

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Packaging 333

BioPharma Dive

SEPTEMBER 26, 2024

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

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BioPharma Dive

SEPTEMBER 26, 2024

Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.

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STAT

SEPTEMBER 26, 2024

Biden administration officials have abandoned their own proposal to require drug companies to disclose the prices and research costs of drugs that are driving up spending in state Medicaid programs. Pharmaceutical companies and lobbying groups heavily pressured the Centers for Medicare and Medicaid Services to abandon the little-noticed idea to create “drug price verification surveys” — they indirectly threatened to sue if the government moved forward with it.

Drug Pricing 328

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 328

pharmaphorum

SEPTEMBER 26, 2024

Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.

Vaccines 115

Vaccines 115

STAT

SEPTEMBER 26, 2024

Patients who received higher doses of buprenorphine, a common medication used to alleviate opioid withdrawal and cravings, were less likely to be hospitalized and less likely to discontinue treatment, according to a new study.  The findings run counter to federal guidelines about buprenorphine dosing. Currently, the Food and Drug Administration recommends a target dose of 16 mg.

Hospitals 306

Hospitals 306

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pharmaphorum

SEPTEMBER 26, 2024

MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac

Chemotherapy 114

Chemotherapy 114

STAT

SEPTEMBER 26, 2024

Facing charges from the Securities and Exchange Commission for misleading claims related to a controversial Alzheimer’s drug candidate, Cassava Sciences and two of the company’s former executives have agreed to pay fines, the company announced Thursday. The news comes on the same day that the SEC filed charges against Cassava, former CEO Remi Barbier, and former senior vice president of neuroscience Lindsay Burns.

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pharmaphorum

SEPTEMBER 26, 2024

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

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STAT

SEPTEMBER 26, 2024

On Wednesday, Congress passed a temporary spending bill that keeps the government funded beyond Sept. 30. Yet, even in light of lawmakers averting a shutdown, there is another end-of-moth deadline looming they’ve largely ignored: expiration of foundational aging and disability legislation called the Older Americans Act (OAA). The OAA supports the delivery of home and community-based social and services that improve the lives, dignity, safety and wellbeing of older adults.

Packaging 316

Packaging 316

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

Drug Patent Watch

SEPTEMBER 26, 2024

The generic drug market is a complex and dynamic environment where multiple factors influence the availability, quality, and pricing of generic drugs. Conducting an effective market analysis is crucial for pharmaceutical companies, policymakers, and healthcare professionals to understand the market dynamics and make informed decisions.

Pharmaceutical Companies 100

Pharmaceutical Companies Pharmaceutical Companies 100

STAT

SEPTEMBER 26, 2024

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. The  deep financial restructuring  announced by Bluebird Bio this week offered another reminder that groundbreaking genetic medicines capable of transforming the lives of people with inherited disease are not now — and may never become — a sustainable business.

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Express Pharma

SEPTEMBER 26, 2024

The Organisation of Pharmaceutical Producers of India (OPPI) has appointed Bhushan Akshikar as its President for a two-year term, effective from 26 September 2024. OPPI, representing global research-based pharmaceutical companies in India, will benefit from Bhushan’s extensive experience in the industry. Bhushan Akshikar has over 13 years of leadership experience with GSK in regions including India, the Middle East, Russia, CIS, and Africa.

Pharmaceutical Companies 100

Pharmaceutical Companies Pharmaceutical Companies 100

STAT

SEPTEMBER 26, 2024

Epic Systems is no stranger to the courtroom. The nation’s largest vendor of electronic health records has fought, and won, legal fights with rivals large and small for many decades. But a new antitrust lawsuit filed this week by Particle Health , an upstart health data company, presents an especially direct threat to Epic’s dominance in the multi-billion dollar market surrounding patient data, legal and health policy experts told STAT.

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pharmaphorum

SEPTEMBER 26, 2024

Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.

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STAT

SEPTEMBER 26, 2024

ARCH Venture Partners has raised $3 billion for a new fund — one of the largest in the biotech industry, and one the VC firm will use to continue its contrarian investment strategy.  The last few years have tested many venture firms: biotech stocks dropped, valuations shifted, and the flow of fresh capital forced many startups out of business before signs of a recovery emerged.

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Express Pharma

SEPTEMBER 26, 2024

More than 50 new greenfield manufacturing plants for pharmaceuticals and medical devices have been completed under the Production Linked Incentive (PLI) scheme. Another 50 new plants are expected to be completed within the next two years. These PLI plants have contributed to $10 billion in exports from India to countries with high regulatory standards, according to Dr Arunish Chawla, Secretary of the Department of Pharmaceuticals, Government of India.

Biosimilars 98

Biosimilars 98

STAT

SEPTEMBER 26, 2024

Within a few days of one another, two teams of accountants released separate estimates on the value of nonprofit hospitals’ tax exemptions. Their wildly different findings underscore the degree to which who’s counting and what they count matters.  The first, a JAMA study published today , pegged that number at $37.4 billion. It factored in the value of forgone federal and state income taxes, sales tax, property tax, federal unemployment tax, charitable contributions from donor

Hospitals 296

Hospitals 296

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

Express Pharma

SEPTEMBER 26, 2024

German drug and development company Evotec, has entered into a technology development partnership with Novo Nordisk to support clinical and commercial manufacturing of stem cell-based therapies, Evotec said on Thursday. Evotec will receive funding for technology development activities in Germany and Italy, research and development funding, an undisclosed upfront payment and possible milestone and royalty payments, it added.

Diabetes 98

Diabetes 98

STAT

SEPTEMBER 26, 2024

WASHINGTON — Pushing back on complaints from Congress this year that her agency’s response to disease outbreaks was sluggish, Dawn O’Connell forcefully defended the Administration for Strategic Preparedness and Response at a STAT event in D.C.  Congress has “extraordinary confidence in our ability to deliver,” she said Thursday, pointing to recent budget increases for ASPR in House and Senate markups of the 2025 Labor and HHS appropriations bill.

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Express Pharma

SEPTEMBER 26, 2024

Merck, said on Wednesday a combination of its experimental drug and blockbuster therapy Keytruda failed a late-stage trial testing it in previously treated patients with a type of colorectal cancer. This is the latest failure in a set of trials studying a combination involving Keytruda at a time the drugmaker seeks to expand its use in types of cancers not yet treated by immunotherapies while facing a loss of patent protection for the drug at the end of the decade.

Immunization 98

Immunization Immunity 98

STAT

SEPTEMBER 26, 2024

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning! Exactly one year ago today, STAT published stories on suicide risk among nurses, the fight from dairy farmers to kill the terms “ oat milk ” and “soy milk,” and the final decision on where ARPA-H would be headquartered.

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Pharmacy Management

BioPharma Dive

SEPTEMBER 26, 2024

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S. in 2019.

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STAT

SEPTEMBER 26, 2024

Why are Genentech’s cancer researchers concerned about the direction of the company? What led Pfizer to pull its sickle cell drug off global markets? And what cake did Adam make for all his podcast colleagues except Elaine? We talk about all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

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Express Pharma

SEPTEMBER 26, 2024

The 10th Annual Pharma Legal & Compliance Summit (PLCS) 2024 will bring together key figures from the pharmaceutical, healthcare, and medical device industries for a day focused on regulatory insights, legal updates, and expert discussions. Organised by Lex Witness, India’s premier legal publication, the summit will take place on October 25, 2024, at Taj Santacruz, Mumbai.

Biosimilars 97

Biosimilars 97

STAT

SEPTEMBER 26, 2024

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. It’s another busy news day, and I’m layering up at home to avoid turning the heater on. Fall is officially here.

Drug Pricing 240

Drug Pricing Drug Development 240

pharmaphorum

SEPTEMBER 26, 2024

BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.

Drug Development 100

Drug Development 100